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2761. A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted

: A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has had IM vaccine administrations and blood draws without any adverse experience, is eligible); Infectious disease: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV RNA positive) treatment for chronic hepatitis C infection in the past year, or active syphilis (positive RPR confirmed by TPHA); Receipt of live attenuated vaccine within

2018 Clinical Trials

2762. VRC 610: Phase I Safety and Pharmacokinetics Study to Evaluate a Human Monoclonal Antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) Administered Alone or Concurrently With MAB VRC- HIVMAB075-00-AB (VRC07-523LS) Via Subcutaneous Injection in Healthy Adults

and 8 injections per dose depending on their weight. Heavier participants will get more injections. Participants will get a ruler and thermometer. They will check their temperature for 3 days after injection(s). They will measure any redness, swelling, or bruising at the injection site. At non-injection visits, participants will have blood drawn and be checked for health changes or problems. Condition or disease Intervention/treatment Phase Healthy Adult Immune Response Biological: VRC-HIVMAB95-00

2018 Clinical Trials

2763. Exertional Exhaustion in Chronic Fatigue Syndrome

serious neurological diseases Brain injury. stroke, severe head injury (concussion, severe motor vehicle accidents), bleeding into brain, have been unconscious for more than 1 day (in a coma), seizures, brain inflammation such as multiple sclerosis or lupus. Metal implants such as prostheses, wires, plates, or screws that may heat up in the magnetic resonance imaging scanner and cause harm. Claustrophobia. Abnormal laboratory and questionnaire results. Heart, lung, kidney, arthritis, autoimmune

2018 Clinical Trials

2764. A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.

(estimated maximum of 4 months from start of stimulation) ] Incidence and intensity of injection site reactions after FE 999302 administration (redness, pain, itching, swelling and bruising) assessed by the subject during the stimulation period [ Time Frame: Immediately after injection of FE 999302 or placebo, 30 minutes after injection, and 24 hours after injection ] Incidence of treatment-induced anti-FE 999302 antibodies, overall as well as with neutralising capacity [ Time Frame: On stimulation Day 1

2018 Clinical Trials

2765. Trauma Acute Pain Treatment With Methoxyflurane Vaporized (PENTHROX®): Efficacy and Safety Study (MEDITA)

to any study-specific activity. In cases where the patient is unable to write autonomously, it must be obtained a verbal consent in presence of a witness that the patient will have to confirm autonomously as soon as (s)he is able Stable, vigilant and collaborative patient i.e. able to understand and communicate with the examiner in order to carry out the study activities Age ≥ 18 years Trauma to the limbs (fracture, dislocation, crushing, bruising) in a single district. N.B. For recruiting, given

2018 Clinical Trials

2766. Neuroimaging Predictors of Bariatric Surgical Outcome

to understand purpose of study as presented in English Exclusion Criteria: Auditory or visual impairment that interferes with test-taking. Mental retardation (WAIS Full Scale IQ<70). Traumatic brain injury with loss of consciousness > 10 minutes or concussion in last 20 days. Presence or history of any medical/neurologic illness that may affect brain physiology (e.g., epilepsy, multiple sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a licensed radiologist

2018 Clinical Trials

2767. Enhancing Brain Training With Virtual Reality

: Be between the ages of 18 and 35. Have no neurologic or vascular disorders/injuries. Specific Inclusion Criteria for the College Athletes with TBI Group. The subject must: Be between the ages of 18 and 35. Be diagnosed with mild TBI (i.e., concussion) within the last two weeks. Specific Inclusion Criteria for the Older Adult Group. The subject must: Be over the age of 65. Have no neurologic or vascular disorders/injuries. Exclusion Criteria: A person will be excluded from the study if he/she: • Is under (...) Update Posted: July 11, 2018 Last Verified: June 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Undecided Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Brain Injuries Brain Injuries, Traumatic Brain Concussion Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System

2018 Clinical Trials

2768. Brain and Gut Plasticity in Mild TBI Following Growth Hormone Therapy

provided by The University of Texas Medical Branch, Galveston: growth hormone Traumatic Brain injury concussion mTBI fatigue cognitive impairment BIAFAC Additional relevant MeSH terms: Layout table for MeSH terms Brain Injuries Fatigue Cognitive Dysfunction Brain Injuries, Traumatic Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Signs and Symptoms Cognition Disorders Neurocognitive Disorders Mental Disorders

2018 Clinical Trials

2769. Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

noted were expected and mild, including redness, bruising, textural changes, hyperpigmentation and tenderness at the injection site. Many other adverse events commonly associated with injections were not observed in any participant throughout the study (i.e., scarring, ulceration, scabbing, purpura, oozing, crusting, blanching, blistering, edema or abrasions). These data indicate that conducting a phase II, dose-escalation, safety and efficacy study in humans is warranted. Based on investigators

2018 Clinical Trials

2770. The Effects of MBSR on Patients With TBI and Chronic Insomnia

used in the Department of Defense (DoD) for the evaluation of post-concussive symptoms in service members (SMs). In addition, the Department of Veterans Affairs (VA) uses the NSI in its comprehensive traumatic brain injury (TBI) evaluation. Scores are summed at initial visit and follow up visit. number of symptoms of moderate, severe, and very severe intensity and a list of the specific symptoms in each of these rating categories. Change in individual symptom scores of two or more points

2018 Clinical Trials

2771. Sildenafil Treatment for Mild TBI

. With respect to chronic TBI, previous studies have demonstrated that sildenafil therapy potentiates cardiovascular reactivity (CVR) in areas of the brain with damaged endothelium. In this proposal, the investigators will test the hypothesis that sildenafil treatment in boxers/Mixed Martial Arts (MMA) fighters soon after concussion normalizes CBF, potentiates CVR, reduces post-concussion symptoms, and improves cognition. Condition or disease Intervention/treatment Phase Vascular System Injuries Concussion (...) , Brain Post-Concussion Syndrome Drug: Sildenafil Citrate Drug: Placebo oral capsule Phase 2 Detailed Description: In this study, 100 professional boxers that experience a concussion will be enrolled, randomized to either placebo or sildenafil (60mg) drug treatment, and arterial spin labeling and BOLD-MRI with hypercapnia will used to assess CBF and CVR, respectively. Symptom reporting, blood biomarkers, and neuropsychological testing will also be conducted. The timepoints for this study are baseline

2018 Clinical Trials

2772. Safety and Immunogenicity of a Candidate MERS-CoV Vaccine (MERS001)

History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) History of serious psychiatric condition likely to affect participation in the study Bleeding disorder (eg. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture Any other serious chronic illness requiring hospital specialist supervision Suspected or known current alcohol abuse as defined by an alcohol intake of greater

2018 Clinical Trials

2773. F-Point Validation Study

medications are permitted to enrol, provided the timing of sampling is outside of 24 hours after the last dose of the medication. Any patient with a known thrombophilia or a known haemophilia. Any patient with a known dysfibrinogenaemia except in the anonymous low fibrinogen group Patients with a known malignancy or autoimmune condition affecting blood clotting A personal history of easy bruising strongly suggestive of a blood clotting disorder Any reason, in the opinion of the investigator that would

2018 Clinical Trials

2774. Efficacy and Safety of AD-35 in Treatment of Subjects With Mild to Moderate Alzheimer's Disease

, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation). History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (eg, cerebral contusion). History or presence of intracranial tumor (eg, meningioma, glioma). Presence of infections that affect the brain function or history of infections that resulted in neurologic sequelae (eg, syphilis, neuroborreliosis, viral or bacterial meningitis/encephalitis,human

2018 Clinical Trials

2775. Efficacy and Safety of Low Dose Ticagrelor in Patients With Unstable Angina Pectoris After Coronary Stent Implantation

on minimal bleeding event as all other bleeding (eg, bruising, bleeding gums, oozing from injection site) not requiring intervention or treatment. Events were adjudicated by an endpoint committee. Other adverse events [ Time Frame: Randomization up to 24 months ] To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee. Experiment examination [ Time Frame: Randomization up to 24 months ] To compare two

2018 Clinical Trials

2776. Modafinil's Effects on Cognition in Remitted MDD

to respond to an adequate trial of modafinil Any past history of head injury or concussion, as confirmed by the Ohio State University Traumatic brain injury (TBI) Identification Short Form Current suicidal ideation (MADRS Item 10 ≤2 or by clinician judgement) History of coronary artery disease, recent (<1 year) myocardial infarction, or unstable angina History of left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, or clinically significant manifestations of mitral valve prolapse

2018 Clinical Trials

2777. Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults

will then be removed. Safety will be assessed by measuring bruising, bleeding, and pain to participant. A follow-up questionnaire will assess pain, bruising, and infection risk. A final visit will assess pain, bruising, and infection risk by a physician. Masking: None (Open Label) Primary Purpose: Basic Science Official Title: Assessing the Safety and Efficacy of the SubQ Assist Implant Insertion Device Actual Study Start Date : November 8, 2018 Estimated Primary Completion Date : November 2019 Estimated Study (...) Completion Date : December 2019 Arms and Interventions Go to Arm Intervention/treatment Experimental: Single arm study: implant insertion Participants in trial will be within a single study arm. All participants will have a placebo subcutaneous implant inserted with the device being studied. The implant accuracy will be assess through palpation and ultrasound depth measurements. The implant will then be removed. Safety will be assessed by measuring bruising and bleeding. A follow-up questionnaire

2018 Clinical Trials

2778. The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine

sustained concussion. A majority of these patients suffer from headaches. Many of these are classified as migraine headache that do not respond to medications. Osteopathic manipulation is practiced by physicians in the United States and has been shown to be beneficial in some migraine patients. However, its use in the management of persistent post-traumatic headaches has not been explored. The investigators will use a randomized cross-over design to evaluate post-traumatic migraine patients' response (...) decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: History of TBI, concussion, post-concussive syndrome Headache

2018 Clinical Trials

2779. RF and PEMF Following Liposuction

immunosuppressive medications. Suffering from hormonal imbalance which may affect weight or cellulite. History of significant lymphatic drainage problems. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment or during the treatment course. History of keloid scarring or of abnormal wound healing. History of being especially prone to bruising. History

2018 Clinical Trials

2780. A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting

., hereditary paraparesis; MELAS [mitochondrial myopathy, encephalopathy, lactic acidosis, stroke] syndrome) Neuromyelitis optica History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjogren's syndrome, Behçet's disease, sarcoidosis) History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression) Vulnerable patients (Patient referred

2018 Clinical Trials

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